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Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

Primary Purpose

Osteoporosis, Postmenopausal

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

0 g SCF

10g SCF

20g SCF

About this trial

This is an interventional prevention trial for Osteoporosis, Postmenopausal focused on measuring Soluble Corn Fiber, Osteoporosis, Bone Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women at least 4 years Postmenopausal

Exclusion Criteria:

Medications affecting bone resorption

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

0g SCF

10 g SCF

20g SCF

Arm Description

Subjects will consume 0 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

Subjects will consume 10 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

Subjects will consume 20 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

Outcomes

Primary Outcome Measures

Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods

41Ca/Ca ratio will be determined by Accelerator Mass Spectrometry. A linear regression model including the data from the non-intervention ratios will determine the predicted 41Ca/Ca ratios over the course of the 350 day study. The percent change of 41Ca/Ca ratios in the 50 day intervention periods from the predicted values will determine the effect of the intervention.

Secondary Outcome Measures

Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker

Fasting serum osteocalcin (OC), a biochemical bone turnover marker

Fasting urine N-terminal telopeptide, a biochemical bone resorption marker

Full Information

NCT ID

NCT02416947

First Posted

April 8, 2015

Last Updated

April 14, 2015

Sponsor

Purdue University

Collaborators

Tate & Lyle Health & Nutrition Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02416947

Brief Title

Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

Official Title

The Effect of Soluble Corn Fiber (SCF) on Bone Resorption in Post-Menopausal Women Using 41Calcium Technology

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Purdue University

Collaborators

Tate & Lyle Health & Nutrition Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed to study the dose response effect of continuous Soluble Corn Fiber (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using the 41Calcium methodology. To further understand the dose response effect of SCF bone biomarkers will be studied. Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as bone biomarkers of resorption.

Detailed Description

Subjects will be dosed with 41Calcium , a long-lived radio isotope, which will become deposited in the skeleton after about 100 days. During this time subjects will collect 24 h urine monthly to monitor the decrease in 41Calcium urinary excretion. Subsequently, the baseline level of 41Calcium urinary excretion will be evaluated over a 50 day baseline period with 24 h urine collections every 10 days. Participants will then be randomized to one of three doses of soluble corn fiber (0,10,20 g/d) to be consumed in two equivalent doses per day for 50 days. Women will collect 24 h urine every 10 days. Each 50 day period will be followed by a 50 day washout period during which the subjects will continue to collect urine every 10 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

Keywords

Soluble Corn Fiber, Osteoporosis, Bone Loss

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0g SCF

Arm Type

Placebo Comparator

Arm Description

Subjects will consume 0 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

Arm Title

10 g SCF

Arm Type

Active Comparator

Arm Description

Subjects will consume 10 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

Arm Title

20g SCF

Arm Type

Active Comparator

Arm Description

Subjects will consume 20 g of SCF in two equal doses as a muffin and a drink, daily for 50 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

0 g SCF

Other Intervention Name(s)

0 g Soluble Corn Fiber

Intervention Description

0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Intervention Type

Dietary Supplement

Intervention Name(s)

10g SCF

Other Intervention Name(s)

10 g Soluble Corn Fiber

Intervention Description

10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Intervention Type

Dietary Supplement

Intervention Name(s)

20g SCF

Other Intervention Name(s)

20 g Soluble Corn Fiber

Intervention Description

20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.

Primary Outcome Measure Information:

Title

Change in 41Ca/Ca ratio in five 24 h urine collections during intervention periods compared to urinary 41Ca/Ca ratios during non-intervention periods

Description

Time Frame

24 h urine collections on days 10, 20, 30, 40, and 50 of each of three intervention periods and 4 non intervention periods

Secondary Outcome Measure Information:

Title

Fasting serum bone specific alkaline phosphatase (BSAP), a biochemical bone formation marker

Time Frame

Fasting serum drawn at the end of each 50 day intervention period

Title

Fasting serum osteocalcin (OC), a biochemical bone turnover marker

Time Frame

Fasting serum drawn at the end of each 50 day intervention period

Title

Fasting urine N-terminal telopeptide, a biochemical bone resorption marker

Time Frame

Fasting urine collected at the end of each 50 day intervention period

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women at least 4 years Postmenopausal Exclusion Criteria: Medications affecting bone resorption

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Connie M Weaver, Ph.D

Organizational Affiliation

Purdue University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

27465372

Citation

Jakeman SA, Henry CN, Martin BR, McCabe GP, McCabe LD, Jackson GS, Peacock M, Weaver CM. Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. Am J Clin Nutr. 2016 Sep;104(3):837-43. doi: 10.3945/ajcn.116.132761. Epub 2016 Jul 27. Erratum In: Am J Clin Nutr. 2017 Mar;105(3):772.

Results Reference

derived

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Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

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